ACTRN12619000108112Not yet recruitingPhase 3
Prospective, double-blind, randomised study of the efficacy of ketamine for oropharyngeal mucositis pain
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Monash Health
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •Patient Inclusion Criteria:
- •Treatment related oral or pharyngeal mucositis with average pain score of >/= 4 on the Brief Pain Inventory (BPI)
- •Males and females aged over 18 years.
- •Able to provide informed consent and complete questionnaires.
Exclusion Criteria
- •Patient Exclusion Criteria:
- •Patients in who significant hypertension or tachycardia would be potentially dangerous.
- •Patients who have previously received ketamine for chronic pain by any route of administration prior to the study within the preceding six months will be excluded. Patients who have received ketamine for an anaesthetic indication, will not be excluded.
- •Patients who have undergone any other procedure or therapy likely to affect pain during the study period.
- •Patients with recent seizures or a history of uncontrolled epilepsy not related to the underlying malignancy.
- •Patients with a documented history of uncontrolled hypertension, cardiac arrhythmias, cardiac failure, ischaemic heart disease or recent history of cerebral vascular accident, cerebral trauma, intracerebral mass or haemorrhage.
- •Patients with a documented history of increased intraocular pressure such as glaucoma.
- •Patients with a known serious psychiatric illness such as schizophrenia, acute psychosis excluding depression and anxiety.
- •Patients with a documented history of acute intermittent porphyria.
- •Patients with a documented history of uncontrolled hyperthyroidism. (Patients receiving thyroid replacement must have a thyroid stimulating hormone (TSH) serum level within the normal range).
- •Patients currently taking prohibited drugs such as rifampicin, carbamazepine, phenytoin and diazepam.
- •Patients currently taking monoamine oxidase inhibitors (MAOIs) or who have been taking non-reversible monoamine oxidase inhibitors within 4 weeks prior to study entry or reversible MAOIs within 2 days of study entry.
- •Patients who have participated in a clinical study of a new chemical entity within the last month, prior to study entry.
- •Any patient who has had an adverse reaction to ketamine in the past.
- •Comorbidities contraindicating the use of ketamine.
- •Severe organ dysfunction.
- •Pregnancy and lactation.
- •All participants are required to use an effective form of contraception.
Investigators
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